The purpose of this study is to determine the medium term efficacy and safety profile of inhaled mannitol, on its own and also as an additional therapy to rhDNase (pulmozyme). In particular, we will assess the impact on: lung function; airway inflammation; sputum microbiology; exacerbations; quality of life; adverse events; exercise tolerance; total costs of hospital and community care; and cost-effectiveness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Great Ormond Hospital for Children
London, United Kingdom
Royal Brompton Hospital
London, United Kingdom
FEV1 after 12 weeks of each of the following treatment regimens: *mannitol only *rhDNase only *mannitol + rhDNase
Time frame: 12 weeks
to compare mannitol to rhDNase on FVC
Time frame: 12 weeks
to assess whether the effects of mannitol are additive to rhDNase
Time frame: 12 weeks
to demonstrate that mannitol does not cause deterioration in airway inflammation
Time frame: 12 weeks
to assess whether mannitol reduces the bacterial load in the lung
Time frame: 12 weeks
to assess whether the effects of mannitol are beneficial to quality of life
Time frame: 12 weeks
to assess whether mannitol, or mannitol + rhDNase are cost-effective compared to rhDNase alone
Time frame: 12 weeks
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